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A quality management intervention to improve clinical laboratory

Godfrey Isouard
Med J Aust 1999; 170 (1): 11-14.
Published online: 24 December 1998

MJA 1999; 170: 11-14
For editorial comment, see Conyers


Abstract

Objective: To assess the effect of a total quality management (TQM) approach on the appropriateness of clinical laboratory testing of patients with acute myocardial infarction.
Design: Retrospective, control-group, quasi-experimental study.
Setting: Two metropolitan teaching hospitals: one involved in the intervention (TQM experimental group); the other had no intervention (control group).
Intervention: A multidisciplinary team involved in the development of improvement strategies, including laboratory testing guidelines, education programs, data collection, monitoring and feedback.
Outcome measures: Total number of requested clinically indicated and non-clinically indicated tests.
Results: The proportion of clinically indicated tests that were requested increased from 77.5% to 88.2% (P < 0.01) and the number of non-clinically indicated tests was reduced by 81.7% with the introduction of the TQM strategies (P < 0.01).
Conclusions: The introduction of a TQM approach has improved the appropriateness of test ordering in acute myocardial infarction. The reduction in non-clinically indicated tests could produce substantial savings in hospital pathology costs, and the increase in clinically indicated tests provides better patient care.


Introduction

The determination of plasma creatine kinase (CK) and creatine kinase-MB fraction (CK-MB) is pivotal in the diagnosis of acute myocardial infarction (AMI).1 However, the inappropriate use of these and other laboratory tests has increased markedly during the past 10-15 years, contributing to escalating healthcare costs2 and undesirable clinical consequences because of false positive results in AMI, often leading to unnecessary further investigations.3

A number of reports have indicated an excessive use of laboratory tests in patients admitted to hospital with AMI or other clinical disorders. One Australian study found that at one hospital up to 20% of all laboratory tests were unnecessary.4 Another found that there were three times as many clinical chemistry tests ordered as were appropriate for patients admitted with chest pain.5 Similarly, a recent study found inappropriate testing of calcium, phosphate and magnesium in the emergency department of a United States teaching hospital.6

The conventional approach to address inappropriate laboratory testing has been to target doctors through education,7 feedback8 and providing information on laboratory testing costs.9 Such measures have had limited success, and in most cases have had limited input from clinicians.10

I have examined the effect of a total quality management (TQM) approach (that was developed and introduced by clinicians and other healthcare professionals) on the appropriateness of clinical laboratory test use in the management of patients with AMI.

Total quality management refers to the overall approach of managing the total aspects of an organisation's quality. In my study, this involves changing the way quality in test use is viewed, focusing on the customer and including everyone involved in its provision and use in the process of continuous improvement. The specific TQM model I used was the FOCUS-PDCA approach to quality improvement (Box 1).11


Methods

Setting and patient groups

The study was conducted from March 1993 to August 1995 at two teaching hospitals in Sydney. Patients at Bankstown-Lidcombe Hospital were designated the "experimental" group, and those at Nepean Hospital were the "control" group. Only the experimental group was subjected to the TQM intervention.

At the time of the study, Bankstown-Lidcombe Hospital was a 454-bed hospital with 21 724 annual admissions from the Emergency Department and 2355 admissions to the Coronary Care Unit (CCU). Nepean Hospital was a 415-bed hospital with 20 485 annual admissions from the emergency department and 1891 admissions to the CCU.

Within the study groups, two subgroups of AMI patients were identified: "suspected AMI" and "confirmed AMI".

The suspected AMI group included all patients who were admitted to the CCU via the emergency department with chest pain and electrocardiographic (ECG) signs suggesting AMI: these were greater than 0.1 mV of ST-segment elevation in two or more limb leads or greater than 0.2 mV in two or more contiguous precordial leads, and the Minnesota code was used to classify Q-wave changes.12

Not all the cases of suspected AMI did in fact progress to AMI. Patients were included in the confirmed AMI group if they had a primary discharge diagnosis in accordance with the World Health Organization criteria.13 The diagnosis was confirmed if the patient had at least two of the following three findings: the presence of a typical history of characteristic chest pain, new ECG changes of pathological Q waves, and an elevation of serum CK to 390 U/L or above during the first 72 hours of admission.

 

Improvement process

A quasi-experimental design involving a pre-intervention and post-intervention phase with a concurrent control was used to test the effect of the TQM approach. The study was conducted in two 15-month stages. The first stage involved the collection of pre-intervention data. In the second stage the TQM intervention took place.

Using the FOCUS-PDCA TQM model, a multidisciplinary team was empowered to make the necessary improvements, which were introduced during the intervention period as they were developed. The team included representatives from all clinical areas involved in the process of laboratory testing. These included the Emergency Department (Director of Emergency, Assistant Director of Nursing, Clinical Nurse Specialist and Senior Medical Officer), CCU (Director of Cardiology, Nurse Unit Manager, Clinical Nurse Specialist), Pathology Department (Director of Pathology, Senior Technologist), and Administration (Deputy Director of Medical Services). The hospital's Quality Assurance Officer was appointed the Quality Advisor for the TQM team.

TQM team meetings were held weekly over the first two months of the 15-month intervention period, and then monthly.

The TQM team established an overall review and improvement of the total systems and processes involved in test ordering. The team's mission statement was To ensure that the pathology services used are appropriate, effective and efficient for supporting clinical care in AMI.

Practice guidelines were introduced for laboratory testing in the management of AMI. Clinicians in the team were actively encouraged to participate in the improvement process. Draft copies of the guidelines were circulated widely to other clinicians for comment. Suggestions for change were considered and incorporated into the guidelines as determined by the team. The guidelines provided details of all recommended laboratory tests during the 72-hour period following the admission of a patient with suspected AMI into hospital.

Strategies were developed for education and training programs, feedback mechanisms and ongoing monitoring of performance through data collection and analysis. To implement the changes, the TQM team assigned responsibility to motivated individuals to accomplish specified tasks. Progress reports were provided at subsequent meetings.

Medical staff requesting laboratory tests for suspected AMI patients were issued with pre-stamped pathology request forms that listed the recommended tests from the guidelines.

 

Clinically indicated tests

Requested laboratory tests were designated as "clinically indicated" if the ordered tests matched those listed in the AMI practice guidelines devised by the team, or if the tests were found to be justified when the patient's records were checked by one of the study's hospital medical officers. Conversely, "non-clinically indicated" tests were all requested tests found to be outside the recommendations of the AMI practice guidelines that could not be justified for inclusion when checked by one of the study's hospital medical officers.

 

Data collection and statistical analysis

Once the suspected AMI patients were transferred to the CCU of the experimental group hospital, an audit was undertaken of the laboratory tests requested and the time and date of each blood collection. The data were collected by me in collaboration with the Senior Technologist of the Pathology Department. The findings on the appropriateness of test use were reported to the Emergency Department and CCU staff, and at the team meetings.

For each of the confirmed AMI groups, the number of clinically and non-clinically indicated tests were retrospectively determined. Group equivalency between the pre-TQM and post-TQM groups was determined using the t test. Only the results for the confirmed AMI groups are presented here.

All data were coded, entered and analysed using SPSS for Windows.14

 

Ethical approval

The study was approved by the Ethics Committees of both the South Western Sydney Area Health Service and the Nepean Health Service.


Results

The experimental and control groups did not differ in age, sex ratio or length of stay in hospital (Box 2).

The proportion of clinically indicated tests that were requested for the experimental group increased from 77.5% before the TQM intervention to 88.2% in the intervention period (Box 3). For the control group, the proportion of clinically indicated tests that were requested did not change significantly (Box 4A).

For the experimental group, the number of non-clinically indicated tests per admission was reduced by 81.7% in the intervention period (Box 4B), whereas for the control group this number did not change significantly.

Overall, the total number of tests requested at the experimental hospital was approximately halved in the intervention period, whereas there was no change at the control hospital (Box 5).


Discussion

The introduction of TQM strategies achieved statistically highly significant improvements to the appropriateness of laboratory test ordering in AMI. The findings were sustained over the 15-month intervention period and were not replicated within the concurrently monitored control group hospital. The findings have a number of potentially important economic and patient care implications.

Firstly, the 81.7% reduction of unnecessary tests may provide a substantial reduction in the overall cost of hospital inpatient pathology services if the TQM strategies were to be successfully introduced to more clinical situations. Such potential savings remain the challenge for future investigations.

Secondly, there was an overall benefit to patient care through the increased use of clinically indicated laboratory tests. In addition, although not reported here, there was a statistically significant improvement to the clinically recommended timing of the blood collections for cardiac enzyme testing.

I have not been able to find any study published in medical and health sciences journals during the past 15 years that has used TQM specifically to improve the appropriateness of clinical laboratory use in AMI. However, the FOCUS-PDCA model has had widespread and successful application within the healthcare system.15-16 As the model is process driven, it is likely to be adaptable to other test-ordering processes.

My study supports the recent findings by Nardella et al of significant cost reductions and increased appropriateness of testing through the use of continuous quality improvement strategies.17 Although Nardella et al did not specifically use the FOCUS-PDCA model, they adopted a similar improvement approach. Methodologically, however, my study provided several strengths, with the inclusion of a pre-test and a concurrent control group to enable substantial control over threats to internal and external validity.

The introduction of the TQM intervention was accompanied by additional staff time spent undertaking activities such as training, meetings, data collection and analysis. There was also medical, nursing and clerical staff time saved as a result of the accompanying improvements to the clerical systems used in test ordering. Although such costs and benefits were not quantified, I suspect that any savings made in staffing time were expended in establishing and maintaining the intervention.

Following the 15-month intervention and the disbandment of the formal TQM team, the AMI laboratory testing guidelines remain in operation. However, recent discussions with key personnel from the original team reveal that the pre-stamped pathology request forms are no longer in use and that compliance with the testing guidelines has generally declined. These observations are consistent with those of other studies where improvements have failed to be sustained once improvement strategies had been completed.18-19

In view of the important economic and patient care implications, further investigations should be undertaken on the effects of the TQM approach in a variety of other clinical laboratory testing situations.


Acknowledgements

This research formed part of a major doctoral study undertaken by the author under the supervision of Professor Graeme Rawson, former Dean of the Faculty of Health, University of Western Sydney, Macarthur, NSW. Thanks also to Ms Margaret Gehrig, Quality Advisor to the study. I also acknowledge the contribution of the staff of the Bankstown-Lidcombe Hospital, particularly the Emergency Departments, Coronary Care Units, Pathology and Clinical Information Departments. Similarly, thanks also to the Clinical Information Department of the Nepean Hospital.


References

  1. Hamm CW. New serum markers for acute myocardial infarction. N Engl J Med 1994; 331: 607-608.
  2. Deeble J, Lewis-Hughes P. Directions for pathology. Background Paper No. 6. Melbourne: National Health Strategy, 1991; 7.
  3. Gama R, Swain DG, Nightingale PG, et al. The effective use of cardiac enzymes and electrocardiograms in the diagnosis of acute myocardial infarction in the elderly. Postgrad Med J 1990; 66: 375-377.
  4. Grantham P, Weinstein S. Reducing pathology test misuse. Aust Health Rev 1993; 16: 16-23.
  5. Ratnaike D, Hunt D, Eilermann R, et al. The investigation of chest pain: audit and intervention. Med J Aust 1993; 159: 666-671.
  6. Rose WD, Martin JE, Abraham FM, et al. Calcium, magnesium and phosphorus: emergency department testing yield. Acad Emerg Med 1997; 4: 559-563.
  7. Hindmarsh JT, Lyon AW. Strategies to promote rational clinical chemistry test utilization. Clin Biochem 1996; 29: 291-299.
  8. Mugford M, Banfield P, O'Hanlon M. Effects of feedback of information on clinical practice: a review. BMJ 1991; 303: 398-402.
  9. Winkens RA, Ament AJ, Pop P, et al. Routine individual feedback on requests for diagnostic tests: an economic evaluation. Med Decis Making 1996; 16: 309-314.
  10. Goldman L. Changing physicians' behavior -- the pot and the kettle. N Engl J Med 1990; 322: 1524-1525.
  11. Hospital Corporation of America. Hospitalwide quality improvement process, strategy for improvement: FOCUS-PDCA. Nashville: Hospital Corporation of America, 1989.
  12. Rose GA, Blackburn H. In: Cardiovascular survey methods. WHO Monograph Series No. 56. Geneva: World Health Organization, 1968; 137-153.
  13. World Health Organization criteria for the diagnosis of acute myocardial infarction. Geneva: World Health Organization Cardiovascular Disease Unit, 1981.
  14. SPSS Inc. SPSS for Windows [computer program]. Version 6.0. Chicago Ill: SPSS Inc, 1992.
  15. Rhew E. Quality improvement project reviews: a tool to accelerate the transformation. Jt Comm J Qual Improv 1994; 20: 79-89.
  16. Schneider PD. FOCUS-PDCA ensures continuous quality improvement in the outpatient setting. Oncol Nurs Forum 1997; 24: 966-969.
  17. Nardella A, Farrell M, Pechet L, et al. Continuous improvement, quality control, and cost containment in clinical laboratory testing. Arch Pathol Lab Med 1994; 118: 965-968.
  18. Reeves CA, Bednar DA. What prevents TQM implementation in health care organisation? Qual Prog 1993; 26: 41-44.
  19. Chan YCL, Ho SJK. Continuous quality improvement -- a survey of American and Canadian healthcare executives. Hosp Health Serv Adm 1997; 42: 525-544.

(Received 24 Oct 1997, accepted 3 Aug 1998)


Author's details

Division of Public Health, University of Western Sydney, Macarthur, NSW.
Godfrey Isouard, BSc, PhD, Lecturer.

Reprints will not be available from the author.
Correspondence: Dr G Isouard, Division of Public Health, University of Western Sydney, Macarthur, PO Box 555, Campbelltown, NSW 2560.
E-mail: g.isouardATuws.edu.au

1: The FOCUS-PDCA model

Find a process to improve

Organise a total quality management team

  • select team members
  • team building

    Clarify laboratory test-requesting process

  • flow charts of test-requesting process
  • identify problems
  • customer requirements

    Uncover causes of poor quality test use

  • causes of variation
  • collect data

    Select process improvement

  • determine proposed improvements
  • prioritise

    Plan process improvement

  • develop improvement strategies
  • education and training development

    Do the improvement

  • pilot test
  • implement strategies
  • collect and analyse data

    Check results

  • check lessons learnt
  • determine how effort could be improved

    Act to hold the gain

  • standardise procedures
  • establish monitoring and feedback processes
  • plan continuous improvement
  • 2: Comparison of characteristics of patients with confirmed acute myocardial infarction, before and during the total quality management intervention

    Experimental group
    Control group
    Pre-TQM intervention period
    n=252
    n=203
    Mean age in years (95% CI)
    60.3 (48.6-74.4)
    59.2 (47.5-71.8)
    Men:women (%)
    71.8:28.2
    77.1:22.9
    Median LOS in days (95% CI)
    8.8 (7.2-12.6)
    8.0 (6.8-11.4)
    TQM intervention period
    n=253
    n=211
    Mean age in years (95% CI)
    61.0 (49.1-77.3)
    59.6 (47.8-72.6)
    Men:women (%)
    74.7:25.3
    70.8:29.2
    Median LOS in days (95% CI)
    8.0 (6.3-11.4)
    7.3 (5.4-10.5)

    TQM=total quality management. CI=confidence interval. LOS=length of stay in hospital.

    3: Changes in the use of clinically indicated tests for the experimental confirmed acute myocardial infarction group

    Pre-TQM intervention period
    TQM intervention period
    Percentage point increase
    Number of tests
    Number of tests
    in indicated tests
    Requested*
    Indicated†
    Ratio A‡
    Requested*
    Indicated†
    Ratio B§
    requested (B-A)
    P
    Sodium, potassium, chloride
    2193
    3394
    64.6%
    2631
    3180
    82.7%
    18.1
    <0.01
    Urea
    0
    0
    --
    0
    0
    --
    --
    --
    Creatinine
    175
    329
    53.2%
    281
    294
    95.6%
    42.4
    <0.01
    Glucose
    310
    529
    58.6%
    375
    522
    71.8%
    13.2
    <0.01
    Calcium, magnesium, phosphate
    75
    81
    92.6%
    24
    28
    85.7%
    -6.9
    <0.01
    Cardiac enzyme profile§§
    1860
    2016
    92.3%
    1962
    2024
    96.9%
    4.7
    0.18
    Liver function tests#
    147
    154
    95.5%
    77
    84
    91.7%
    -3.8
    <0.01
    Cholesterol/triglyceride
    479
    504
    95.0%
    438
    506
    86.6%
    -8.5
    <0.01
    Free thryoxine, thyrotropin
    30
    42
    71.4%
    20
    26
    76.9%
    5.5
    <0.01
    Miscellaneous clinical chemical tests
    116
    116
    100.0%
    86
    86
    100.0%
    0
    --
    All clinical chemical tests
    5385
    7165
    75.2%
    5894
    6750
    87.3%
    12.2
    <0.01
    Automated blood count**
    1136
    1304
    87.1%
    1028
    1148
    89.6%
    2.4
    0.20
    Prothrombin index
    252
    252
    100.0%
    253
    253
    100.0%
    0
    --
    Miscellaneous haematology tests
    24
    24
    100.0%
    45
    45
    100.0%
    0
    --
    All haematology tests
    1412
    1580
    89.4%
    1326
    1446
    91.7%
    2.3
    0.15
    Urine microexamination
    11
    11
    100.0%
    14
    14
    100.0%
    0
    --
    Miscellaneous microbiology tests
    16
    16
    100.0%
    28
    28
    100.0%
    0
    --
    All microbiology tests
    27
    27
    100.0%
    42
    42
    100.0%
    0
    --
    All tests
    6800
    8772
    77.5%
    7262
    8238
    88.2%
    10.6
    <0.01

    TQM=total quality management. *Clinically indicated tests that were requested. †Total number of tests that were clinically indicated but not necessarily requested. ‡Pre-TQM tests requested/pre-TQM tests indicated. §TQM tests requested/TQM tests indicated. §§Creatine kinase and creatine kinase-MB. #Total bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyltransferase, alkaline phosphatase, protein, albumin. **Haemoglobin, white cell count, red cell count, platelets.

    4: Comparison of the changes in the use of clinically indicated tests (A) and non-clinically indicated tests (B) for the experimental and control confirmed AMI groups

    A
    Pre-TQM intervention period
    TQM intervention period
    Percentage point increase
    Number of tests
    Number of tests
    in indicated tests
    Requested*
    Indicated†
    Ratio A‡
    Requested*
    Indicated†
    Ratio B§
    requested (B-A)
    P
    Experimental group
    6800
    8772
    77.5%
    7262
    8238
    88.2%
    10.6
    <0.01
    Control group
    7340
    8933
    82.2%
    7399
    9200
    80.4%
    -1.8
    0.19

    B
    Pre-TQM intervention period
    TQM intervention period
    Reduction in
    Total number of tests requested
    Number of tests per admission
    Total number of tests requested
    Number of tests per admission
    non-clinically indicated tests per admission
    P
    Experimental group
    9667
    38.4
    1776
    7.0
    81.7%
    <0.01
    Control group
    4890
    24.1
    4848
    23.0
    4.6%
    0.48

    AMI=acute myocardial infarction. TQM=total quality management. *Clinically indicated tests that were requested. †Total number of tests that were clinically indicated but not necessarily requested. ‡Pre-TQM tests requested/pre-TQM tests indicated. §TQM tests requested/TQM tests indicated.

    5: Total number of tests requested in the experimental and control confirmed acute myocardial infarction groups

    Pre-TQM intervention period
    TQM intervention period
    Total
    Indicated*
    Not indicated†
    Total
    Indicated*
    Not indicated†
    Experimental group
    16467
    6800
    9667
    9038
    7262
    1776
    Control group
    12230
    7340
    4890
    12247
    7399
    4848

    TQM=total quality management. *Number of clinically indicated tests requested. †Number of non-clinically indicated tests requested.

    Received 15 November 2018, accepted 15 November 2018

    • Godfrey Isouard


    Correspondence: 

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